Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

GQX — Predicate Candidate Screening

11 FDA 510(k) clearances under this product code; the 50 most recent screened below.

126 daysmedian FDA review time

239 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K951799	VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY	Light Diagnostics	1996-03-20	336	0
K911301	VZV IGM TEST	Gull Laboratories, Inc.	1991-07-17	114	0
K883427	VIRGO(R) VZV-IGG ELISA	Electro-Nucleonics, Inc.	1989-03-10	207	1
K875358	VZV TEST	Gull Laboratories, Inc.	1988-03-31	91	0
K863317	ENZYGNOST ANTI-VZV IGG TEST	Behring Diagnostics, Inc.	1987-04-22	239	0
K853540	FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY	Idt, A Division of Whittaker M.A. Bioproducts	1986-02-04	165	0
K852930	VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO	Microbix Biosystems, Inc.	1985-11-12	126	0
K842096	GLB VARICELLA-ZOSTER VIRUS FLUORESCENT	Great Lakes Bioscience	1985-01-07	227	0
K841526	ORTHO VARICELLA-ZOSTER VIRUS IDENT.	Ortho Diagnostic Systems, Inc.	1984-06-25	74	0
K770806	VARICELLA-ZOSTER FA LABELLED (8-321 RF)	Flow Laboratories, Inc.	1977-05-20	17	0
K770810	VARICELLA-ZOSTER FA LABELED PRESERUM	Flow Laboratories, Inc.	1977-05-20	17	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda